Prevention of oral mucositis in patients with head and neck cancer undergoing radiotherapy Cancer
Conditions
Interventions
The study will employ a pragmatic mixed-methods randomised parallel-group exploratory design to determine the feasibility of giving a herbal extract within an NHS cancer care setting. The study will c
Sponsors
University of West London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients due to receive radiotherapy (any regime), or concurrent chemoradiotherapy 2. Patients of any gender and 18 years or older 3. Patients willing to participate in the study and be randomised to one of the two treatment arms 4. Patients at least 2 weeks post-surgery
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to participate 2. Patients currently taking turmeric supplements 3. Patients allergic to turmeric 4. Patients unable to ingest capsules 5. Patients with oral lesions unrelated to the treatment or malignancy 6. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a future definitive trial; as such, its primary outcome measures evaluate: 1. Recruitment processes and resources 1.1. Eligibility: The number of patients with cancer eligible for recruitment will be assessed through site referral counts, on-site researcher monitoring, and stakeholder qualitative interviews at recruitment. 1.2. Recruitment (Participation): The ability to recruit patients into the study will be measured by the number of patients consenting, on-site researcher monitoring, and qualitative interviews with stakeholders and patients during recruitment. 1.3. Recruitment (Decliners): The number of patients declining to participate and their reasons will be evaluated through site monitoring and qualitative interviews with stakeholders and patients at recruitment. 1.4. Randomisation: Willingness to be randomised will be explored through patient qualitative interviews at the point of randomisation. 1.5. Retention: Retention across the duration of the intervention will be measured using quantitative dropout data and qualitative interviews with patients and stakeholders during the intervention period. 1.6. Long-term Follow-up: Long-term patient follow-up will be assessed by completion and dropout rates at each stage and qualitative feedback from patients and stakeholders during follow-up. 1.7. Study Timeline: The study timeline will be evaluated by measuring the time taken to recruit, complete the study, and conduct data collection and analysis across the study duration. 2. Intervention management and procedures 2.1. Adherence: Adherence to the turmeric intervention will be assessed through participant adherence data and qualitative feedback from participants and stakeholders during the intervention period. 2.2. Acceptability (Intervention): Acceptability of the turmeric intervention will be evaluated through qualitative interviews with participants and stakeholders during the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures that will be evaluated within this feasibility study are as follows: 1. Questionnaire Acceptability: Acceptability of the selected questionnaires and patients’ willingness to complete them will be assessed through completion rate data and patient feedback from qualitative interviews during questionnaire administration. 2. Descriptive Statistics: Means and standard deviations of patient-reported outcome measures will be described through quantitative data analysis during the study. 3. Outcome Usefulness: Usefulness of study outcome measures will be evaluated by correlating quantitative outcomes with qualitative patient interviews during the study. 4. Sample Size Calculation: A sample size calculation for a future study will be developed using power calculations based on quantitative data collected during the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactSaul Berkovitz
Outcome results
None listed